1207956-Q&A.pdf
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- Solicitation number
- FDA-19-SOL-1207956
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Questions and Answers.
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| File | Type | Posted |
|---|---|---|
| FDA-19-SOL-1207956.pdf | ||
| Attachment-1-Subcontracting_Plan.doc | DOC document |
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FDA-19-SOL-1207956: Questions and Answers
Q.1.) Experimental Design table 1: Group 2 “cigarette” –does this refer to conventional reference cigarette (such as 3R4F)?
A.1.) The cigarette group refers to top market share commercial cigarettes.
Q.2.) E-liquid formulation test materials are to be aerosolized using the electronic cigarette device?
A.2.) Yes, the selected e-liquid test materials will be aerosolized using an appropriate corresponding e-cigarette device.
Q.3.) Will the selected e-cig types be “disposable cig-like” or tank type or capable of using pods?
A.3.) The type of e-cigarettes selected may include any high market share type, including tank and pod systems. The objective of the pivotal study is comparative toxicity of different e-cigarette products, so a variety of product types will be selected.
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